Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| FDC RSG/SIMV 4/40 mg | Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16. | 0 | None | 0 | 47 | 4 | 47 | View |
| FDC RSG/SIMV 4/80 mg | Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks. | 0 | None | 0 | 44 | 4 | 44 | View |
| FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. | 0 | None | 1 | 46 | 10 | 46 | View |
| RSG 4 mg | Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16. | 0 | None | 0 | 48 | 4 | 48 | View |
| RSG 8 mg | Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16. | 0 | None | 3 | 46 | 4 | 46 | View |
| FDC RSG/SIMV 8/40 mg | Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16. | 0 | None | 1 | 45 | 3 | 45 | View |
| SIMV 40 mg | Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16. | 0 | None | 0 | 46 | 5 | 46 | View |
| SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. | 0 | None | 0 | 47 | 6 | 47 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |